FAQ's on licensing Ionising Radiation

Why do I need a licence before I can use ionising radiation?

Under Article 4 of S.I. No.125 of 2000 a licence is required to carry out practices involving ionising radiation.

When do I need a licence?

Any business or organisation which intends to become involved in storing, using, transporting, or disposing of radioactive materials, irradiation equipment or other sources of ionising radiation, must apply to the EPA for a licence before they acquire the radioactive substance or irradiating apparatus.

Are there any exemptions?

As a general rule, all practices which use radioactive substances or sources must hold a valid licence from the EPA. However, a licence is not required where the radioactive substance or irradiating apparatus is exempted under Article 5 of S.I. No.125 of 2000.

I have a dental practice and intend to acquire a dental X-ray machine. How should I proceed?

The completed application must be accompanied by a radiation shielding assessment report for the facility carried out by your RPA and a completed radiation risk assessment form. These documents are to be uploaded on the ‘Document’ tab in EDEN.

Upon receipt of the documentation, an invoice will be forwarded by the EPA’s Office of Radiological Protection to the applicant detailing the licence fee payable. If all documentation is in order, a licence will be issued to the dental practice authorising it to take custody of the X-ray unit.

The initial licence will be for custody of the X-ray unit and its use for commissioning purposes only. The X-ray unit may not be used for clinical purposes until it has been commissioned by the appointed RPA.

Who will commission the X-ray unit and when can I use it?

The RPA will carry out tests on the unit to verify that it is fit for purpose i.e. clinical use. Upon receipt of satisfactory commissioning reports, the licensing restriction will be removed and an amended Schedule 2 issued. The X-ray unit can now be used on patients.

Are there different categories of licensee?

Licences are divided into seven broad categories, covering the different types of practice. The broad categories cover the medical, dental, veterinary, industrial, distribution, research and educational sectors, with a further category for others (mainly state agencies).

What if I want to export or import a sealed source of radiation?

If you intend to import / export a sealed radiation source from / to another European Union Member State, you must complete a shipment document, known as a 1493 form.

If you are refused a licence you cannot obtain the radioactive substance or irradiating apparatus.

How long will it take to process my application?

It normally takes up to one month to process a licence application though this can vary depending upon the complexity of the application.

You should apply for a licence as soon as possible but no later than one month before the date that you intend to acquire the irradiating apparatus or radioactive substance.

Who should make the licence application on behalf of my company?

The licence application should be made in the name of a senior manager – e.g. the General Manager, the Managing Director, the Hospital Administrator, the Chief Executive or an equivalent.

What information must I include in my application form?

You will be asked to provide detailed information about your business or practice, and the sources of radiation which you intend to acquire.

Prior to granting a licence you will have to demonstrate to the EPA’s Office of Radiological Protection that appropriate radiation protection arrangements are in place. These can be demonstrated by submitting appropriate Radiation Safety Procedures, a detailed risk assessment, a plan of your facilities and other relevant information. Our website has details on how to apply and pay for your licence.

What are Radiation Safety Procedures?

In addition to meeting general legal obligations, licensees must also draw up their own Radiation Safety Procedures, specific to the practice. These are often referred to as ‘local rules’.

The Radiation Safety Procedures should deal with matters such as

Dosimetry

Designation of controlled and supervised areas

Radiation labels and notices

Testing and calibration

Training of Staff

How often should Radiation Safety Procedures be revised?

Radiation Safety Procedures should always be revised whenever new radiation sources are acquired or other significant changes occur within the practice. Even where there have been no changes, the procedures should be reviewed annually; this review date should be included on the front cover of the document.

What checks are carried out on licensees?

The EPA’s Office of Radiological Protection routinely carries out inspections to ensure that licensees are in compliance with safety procedures and both regulatory and licensing conditions.

What if I fail to comply with a regulatory or licensing condition?

The EPA has a number of options for dealing with failure to comply with licensing conditions. These include

Enforcing licensing conditions within a prescribed timescale

Suspending the licence

Withdrawing the licence

Prosecuting the licensee.

The decision will depend upon the seriousness of the breach of conditions.